Posted 26 January 2023
Job type Permanent
Contact NameValerie Kalna

Job description


An opportunity has arisen for seasoned drug safety professional to join global leading contract research organization providing services to the pharmaceutical industry as EU QPPV.

The role is permanent, full-time and home-based in Ireland or Portugal.

You will be responsible for
  • Acting as EU QPPV for assigned clients
  • Acting as single POC for the competent authorities on a 24-hour basis, providing prompt response to any requests
  • Acting as POC during inspections
  • Providing oversight over the functioning of the system e.g. SOPs, contractual arrangements, database operations, compliance data regarding quality, completeness and timeliness of expedited reporting and submission of periodic update reports, audit reports and training of personnel in relation to pharmacovigilance
  • Supporting the review and sign-off of protocols of post-authorisation safety studies conducted in the EU or pursuant to a RMP agreed in the EU
  • Ensuring conduct of submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP
  • Ensuring the necessary quality, including the correctness and completeness of pharmacovigilance data submitted to the competent authorities
You will bring
  • Life Science degree (Medical degree or higher medical education preferable
  • 8+ years in PV including previous experience acting as EU QPPV or Deputy QPPV
  • In-depth knowledge of drug safety regulations, industry practices and standards (ICH, GVP, GCP, CIOMS, etc.)
  • Ability to assign workload and oversee junior staff
  • Excellent written and verbal communication skills in English
If you don’t want to miss out on this opportunity, please get in touch ASAP.
Phone: 0203 892 8777